Qualify high-risk excipient suppliers and release only tested lots

Trace each lot of propylene glycol, glycerin, sorbitol or similar excipients to its original manufacturer, and test every container for diethylene glycol and ethylene glycol. Quality Assurance can release only lots that pass and match the regulator's batch record, and suspend failing suppliers.

Starts when

A request to add or change a supplier of a listed high-risk excipient, or receipt of any lot of such an excipient at the plant.

Runs: Per incoming lot, often weekly for liquid-oral manufacturers, plus each new or changed supplier.

People in the process

QQuality AssuranceProcess Owner
PProcurementParticipating Team
SStoresParticipating Team
QQuality ControlParticipating Team

The process is a starting point. The standards are yours.

Configure by product, authorisation and destination market. Regulatory Affairs and authorised quality personnel retain product-change, submission and batch-release decisions. Safety reporting and UCPMP requirements use the applicable reviewed scope.

Keep the work connected.

Quality Assurance

Investigate and respond to NSQ reports on drug batches

Verify a government analyst report or NSQ alert against batch records, distribution data and the retained sample, logging the date of service. Quality Assurance and Legal can decide whether to contest or recall, and reply to the drug controller with root-cause findings.

RQLS

Quality Assurance

Execute drug batch recalls and report closure to regulators

Trace every consignee of the recalled batch from dispatch records, and reconcile quantities manufactured, distributed and returned before supervised destruction or reprocessing. Quality Assurance can follow up every shortfall and give the licensing authority a closing report with root cause and corrective actions.

RSSLF

Regulatory Affairs

Implement NPPA ceiling price revisions across invoicing and stock

Map each NPPA ceiling price notification or annual revision to affected products, compute the new MRP and apply it to price masters, packs and channel stock. Regulatory Affairs can circulate revised price lists with proof of dissemination and answer any overcharging notice.

FCSIL

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